Chronic ProstatitisPhase 2CP/CPPSNCT03500159
Efficacy and Safety of AQX-1125 in Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Phase 2 study testing AQX-1125 200 mg in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by Aquinox Pharmaceuticals (Canada) Inc. at 27 sites in 2 countries.
Trial summary
This is a randomized, multi-center, double-blind, parallel-group study, enrolling approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week treatment with AQX-1125 (active drug) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- What is being tested?
- AQX-1125 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 18 Apr 2018to 17 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements
- Males, ≥18 and ≤80 years of age at Screening Visit 1
- Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)
- Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months
- Must be capable of voiding independently for 30 days prior to screening
Who cannot join
- Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis
- Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes
- Relief of pelvic pain after voiding
- Post-void residual volume >150 mL
- Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1
- History of previous prostate or bladder intervention within 1 month of Screening Visit 1, history of microwave therapy, transurethral resection of the prostate, transurethral radiofrequency thermotherapy, transurethral incision of the prostate, transurethral needle ablation, transurethral laser vaporization of the prostate, Urolift®, Rezum, and other urological interventions within 6 months of Screening Visit 1
Show all 14Show fewer
- Unilateral testicular or scrotal pain as the sole symptom of CP/CPPS
- Ongoing, symptomatic urethral stricture disease
- Neurologic disease or disorder affecting the bladder, ability to void spontaneously, or directly contributing to urinary symptoms (e.g., multiple sclerosis, autonomic neuropathy)
- Severe, excruciating pain during rectal exam (i.e. an "inability to perform the exam")
- History of chronic substance abuse, dependency or abuse of opiates, or other narcotics within the last 2 years
- Any prior history of pelvic cancer (e.g., colorectal, genitourinary) or treatment (radiation or chemotherapy) thereof
- Major surgery within 3 months prior to Screening Visit 1
- Have any other condition/disease which, in the opinion of the Investigator, could compromise subject safety or interfere with the subject's participation in the study or in the evaluation of the study results.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States23 sites
Site 1011
Albuquerque, New Mexico, 87109
Site 1021
Charlotte, North Carolina, 28207
Site 1001
Cleveland, Ohio, 44195
Site 1013
Coeur d'Alene, Idaho, 83814
Site 1022
Dallas, Texas, 75231
Site 1026
Homewood, Alabama, 35209
Site 1023
Jeffersonville, Indiana, 47130
Site 1028
Laguna Hills, California, 92653
Site 1009
Lake Success, New York, 11042
Site 1018
Los Alamitos, California, 90720
Site 1016
Los Angeles, California, 90048
Site 1020
Los Angeles, California, 90048
Site 1010
Mobile, Alabama, 36608
Site 1027
New Port Richey, Florida, 34653
Site 1017
Oklahoma City, Oklahoma, 73120
Site 1007
Philadelphia, Pennsylvania, 19140
Site 1008
Raleigh, North Carolina, 27612
Site 1002
Royal Oak, Michigan, 48072
Site 1012
Shreveport, Louisiana, 71106
Site 1015
Springfield, Illinois, 62769
Site 1004
Tucson, Arizona, 85710
Site 1014
West Des Moines, Iowa, 50266
Site 1019
Wilmington, North Carolina, 28401
Canada4 sites
Site 1005
Brampton, Ontario, L6T 4S5
Site 1025
Kingston, Ontario, K7L 3J7
Site 1003
Oakville, Ontario, L6H 3P1
Site 1024
Toronto, Ontario, M6A 3B5
About this study
Official title: A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Efficacy and Safety of AQX-1125 (200 mg) in Male Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
This is a randomized, multi-center, double-blind, parallel-group study, enrolling approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week treatment with AQX-1125 (active drug) compared to placebo.
The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or placebo in a 1:1 ratio across approximately 30 centers in North America (United States and Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety follow-up call at 3 months and visit at 6 months post last dose, for a total study duration of about 41 weeks.
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Being tested
- AQX-1125 200 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQX-1125 200 mgDrug
Also called Rosiptor
Synthetic SHIP1 activator
PlaceboDrug
Appearance and weight matched tablets without the active product ingredient
| Study group | Role | What they receive |
|---|---|---|
| AQX-1125 | Experimental | AQX-1125 200 mg Receives: Drug: AQX-1125 200 mg |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)
Measured: 12 Weeks
Secondary outcomes (14)
Change From Baseline to Week 12 in NIH-CPSI
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscale and all domains total score
Measured: 12 Weeks
Change From Baseline to Week 12 in IIEF-EF
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in Male sexual health as measured using the International Index of Erectile Function Questionnaire, Erectile Function Domain (IIEF-EF)
Measured: 12 Weeks
Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)
Measured: 12 Weeks
Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average and maximum pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded on paper-based questionnaire at clinic visits.
Measured: 12 Weeks
Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary)
Measured: 12 Weeks
Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints
Change from Baseline at each clinic visit for AQX-1125 200 mg compared to placebo for; Mean of maximum daily pelvic pain score (eDiary), NIH-CPSI pain subscale and all domains total score, IIEF-EF, Mean of average daily pelvic pain scores (eDiary), average and maximum pelvic pain (Paper-based NRS in clinic), and 24-hour voiding frequency (eDiary)
Measured: 16 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12
Measured: 12 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12
Measured: 12 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12
Measured: 12 Weeks
The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement in maximum daily pelvic pain (mean) based on a standardized 11-point numeric rating scale (NRS) recorded by eDiary at Week 6 and 12
Measured: 12 Weeks
The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement NIH-CPSI subscale at Week 6 and 12
Measured: 12 Weeks
Response to Treatment
Response to treatment as defined by a decrease in maximum daily pelvic pain (eDiary) at Week 12 with a decrease or no change to concomitant analgesic medication use.
Measured: 12 Weeks
Discontinuation of Study Medication Due to Treatment Failure
Measured: 12 Weeks
Frequency and Severity of Adverse Events (AEs)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start18 Apr 2018
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Shoskes, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500159
- Sponsor's protocol ID
- AQX-1125-205
- Acronym
- CP/CPPS
- Status last verified
- Dec 2018
- First submitted
- 4 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Efficacy and Safety of AQX-1125 (200 mg) in Male Subjects With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- ClinicalTrials.gov ID
- NCT03500159
- Acronym / sponsor ID
- CP/CPPS / AQX-1125-205
- Conditions
- Chronic Prostatitis, Chronic Pelvic Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 9 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-center, double-blind, parallel-group study, enrolling approximately 100 male subjects diagnosed with CP/CPPS to evaluate the effect of 12-week treatment with AQX-1125 (active drug) compared to placebo.
The subjects will be randomized to receive orally once-daily either AQX-1125 (200 mg) or placebo in a 1:1 ratio across approximately 30 centers in North America (United States and Canada). The study will consist of a screening period of up to 3 weeks, a 12-week treatment period followed by a 4-week off drug safety follow-up period, and an ophthalmic safety follow-up call at 3 months and visit at 6 months post last dose, for a total study duration of about 41 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQX-1125 | Experimental | Drug: AQX-1125 200 mgAQX-1125 200 mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent and the willingness and ability to comply with all aspects of the study requirements
- Males, ≥18 and ≤80 years of age at Screening Visit 1
- Have pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause, and have a physician diagnosis of CP/CPPS (NIH Prostatitis Category III)
- Subjects must agree to use a condom for sexual intercourse from Screening Visit 1 until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months
- Must be capable of voiding independently for 30 days prior to screening
Key exclusion criteria (14 listed)
- Diagnosis of NIH Prostatitis Categories I (acute prostatitis) or II (chronic bacterial) prostatitis
- Diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS) with symptoms of pain, pressure, or discomfort perceived to be related to the bladder, and associated lower urinary symptoms for >6 weeks in the absence of infection or other identifiable causes
- Relief of pelvic pain after voiding
- Post-void residual volume >150 mL
- Have had an unresolved (positive bacterial urine culture) urinary tract infection within 8 weeks (inclusive) prior to Screening Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQX-1125 200 mgAlso: RosiptorSynthetic SHIP1 activator | Drug | AQX-1125 |
| PlaceboAppearance and weight matched tablets without the active product ingredient | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)
Time frame: 12 Weeks
Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)
14 secondary outcomes
Change From Baseline to Week 12 in NIH-CPSI
Time frame: 12 Weeks
Change From Baseline to Week 12 in IIEF-EF
Time frame: 12 Weeks
Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),
Time frame: 12 Weeks
Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic
Time frame: 12 Weeks
Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)
Time frame: 12 Weeks
Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints
Time frame: 16 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA
Time frame: 12 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C
Time frame: 12 Weeks
Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S
Time frame: 12 Weeks
The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo
Time frame: 12 Weeks
The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo
Time frame: 12 Weeks
Response to Treatment
Time frame: 12 Weeks
Discontinuation of Study Medication Due to Treatment Failure
Time frame: 12 Weeks
Frequency and Severity of Adverse Events (AEs)
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Shoskes, MD principal investigator
The Cleveland Clinic
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQX-1125 200 mg in people with Chronic Prostatitis and Chronic Pelvic Pain Syndrome, run by Aquinox Pharmaceuticals (Canada) Inc. at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.